Mental HealthNCT05659030
The Effect of Midwife-led Education Based on Pender's Health Promotion Model on Perinatal Mental Health of Migrant Women
A study testing Education in people with Mental Health and Perinatal Care, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study was conducted to evaluate the effects of midwife-led Pender's Health Promotion Model-based education given to immigrant women on perinatal mental health. The study was conducted with 52 intervention and 54 (n=48 in the post-test) control groups. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Perinatal Care
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 9 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer to participate in the study,
- Be over 18 years of age,
- Literate,
- Be of Syrian nationality and native Arabic,
- Be primiparous or multiparous,
- Be in the 28th-34th week of pregnancy.
Who cannot join
- Having a diagnosed risky pregnancy,
- Having a diagnosed mental illness (psychiatric report status, illness diagnosed by a psychiatrist and receiving treatment),
- Being benefited from psychological counseling, psychotherapy etc. services,
- Being excluded or excluded from the research at any stage of the research.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled experimental study was conducted to evaluate the effects of midwife-led Pender's Health Promotion Model-based education given to immigrant women on perinatal mental health. The study was conducted with 52 intervention and 54 (n=48 in the post-test) control groups. The study consisted of five interviews. The intervention group received 3 modules of training, and the control group received routine clinical care.
Read the detailed description
This randomized controlled experimental study was conducted to evaluate the effects of midwife-led Pender's Health Promotion Model-based education given to immigrant women on perinatal mental health. The study was conducted with 52 intervention and 54 (48 in the post-test) control groups. The study consisted of five interviews. Data were collected using an introductory information form, perinatal mental health information form, Edinburgh Postnatal Depression Scale and Perinatal Anxiety Screening Scale. Appropriate statistical analyses were performed in the analysis of data showing non-parametric distribution. The intervention group received 3 modules of training, and the control group received routine clinical care. The depression scores of the women in the intervention group did not show any significant difference over time, while the scores of the control group showed a significant difference. Depression scores between the groups showed significant differences in the third and fourth interviews. The anxiety scores of the women in the intervention and control groups showed a significant difference over time. No significant difference was observed between the groups in terms of anxiety scores. It can be said that the education based on Pender's Health Promotion Model has a protective and improving effect on perinatal health.
- Conditions
- Mental Health, Perinatal Care
- Being tested
- Education
- Keywords
- Midwifery, human migration, mental health, perinatal care
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
In order to develop the training material, first of all, a literature review will be made and a training booklet will be prepared. The training booklet will be submitted to expert opinion and a pilot application will be made by giving its final form. The training content is based on Pender's Health Promotion Model, which consists of 3 components.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | It is planned to provide training on perinatal mental health to the experimental group in order to eliminate the lack of knowledge of women and to raise awareness. The pre-test will be applied during the pregnancy period before the training. These trainings, which will be held during pregnancy, consist of 3 modules. A training booklet in their preferred language (Turkish or Arabic) will be distributed to women at the end of each module. In addition, the effectiveness of the training will be evaluated at the end of each module and the knowledge deficiencies of women will be eliminated. A module training will be given every week and the training will be completed within three weeks. The effectiveness of the training will be evaluated in the postpartum period with the post-test. Receives: Other: Education |
| Control | No intervention | Routine clinical care will be given to women in the control group. The pre-test will be applied during the pregnancy period and the post-test will be applied in the postpartum period. At the end of the post-test, three module training booklets will be distributed to the women in their preferred language (Turkish or Arabic). In line with their needs, the information deficiencies they request will be corrected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal Mental Health Education Evaluation Form
Change from the level of knowledge and awareness about perinatal mental health. An increase in the score is interpreted as an increase in the level of knowledge and awareness about perinatal mental.
Measured: pre-intervention, immediately after the intervention, after 1 month.
Edinburgh Postnatal Depression Scale
Change from the prenatal and postnatal depression. An increase in the score is interpreted as an increase in perinatal depression symptoms. A score of 12 and above indicates the presence of depression.
Measured: pre-intervention, immediately after the intervention, after 1 month.
Perinatal Anxiety Screening Scale
Change from prenatal and postnatal anxiety. An increase in the score is interpreted as an increase in perinatal anxiety symptoms. A score of 26 and above indicates the presence of anxiety.
Measured: pre-intervention, immediately after the intervention, after 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Jun 2023
- Primary completion1 Nov 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayseren Cevik, Cukurova University
- Investigators
- Ayseren Cevik, Msc, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659030
- Sponsor's protocol ID
- 04.11.2022/34
- Status last verified
- Jan 2025
- First submitted
- 5 Dec 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No